510(k) Report

FDA applicant

Monebo Technologies, Inc.

Austin, TX4 decisions2005–20260 recalls

FDA records 4 decisions for Monebo Technologies, Inc. (Austin, TX) from 2005 to 2026: 4 510(k) clearances. Most are in product codes DPS (Electrocardiograph) and DRX (Electrode, Electrocardiograph). Its devices cite 8 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Monebo Technologies, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2007

2007: 22026 (partial year): 1
2007high 2 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Monebo Technologies, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Monebo Technologies, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • DPSElectrocardiograph3decisions
  • DRXElectrode, Electrocardiograph1decision

Whose devices does it build on?

Its devices cite 8 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 12 times; 1 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K062282Monebo Automated Ecg Analysis and Interpretation Software Library, Version 3.0Monebo Technologies, Inc. · 20079cite it
  • K063044Cardiobelt Electrode BeltMonebo Technologies, Inc. · 20072cite it
  • K043380Monebo Automatic Arrhythmia Detection Software Library, Version 1Monebo Technologies, Inc. · 20051cites it

What has FDA decided for it lately?

  • K260640Kinetic Software LibraryMonebo Technologies, Inc. · 2026
  • K063044Cardiobelt Electrode BeltMonebo Technologies, Inc. · 2007
  • K062282Monebo Automated Ecg Analysis and Interpretation Software Library, Version 3.0Monebo Technologies, Inc. · 2007
  • K043380Monebo Automatic Arrhythmia Detection Software Library, Version 1Monebo Technologies, Inc. · 2005

All 4 as Monebo Technologies, Inc. →